Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial.

ABSTRACT

PURPOSE: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox) and 0.1% dexamethasone (Maxidex) for the prevention of infection and control of inflammation after cataract surgery. SETTING: The ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil. METHODS: A prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days -2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up. RESULTS: There was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had < or = 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups (p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery. CONCLUSION: Treatment with the combined moxiflox acin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.